Address
Form of workJob Title
Quality Analyst II
Requisition
JR000013799 Quality Analyst II (Open)
Location
Raleigh, NC (Pharma) - USA033
Additional Locations
Raleigh, NC
Job Description
SUMMARY OF POSITION:
The Quality Analyst II serves as the primary for batch record review. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts.
ESSENTIAL FUNCTIONS:
ADDITIONAL FUNCTIONS:
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent.
Associates or Technical degree or higher preferred.
Experience:
Competency in MS Word, Excel, and Adobe is required.
1-3 years pharmaceutical manufacturing experience preferred.
Preferred Skills/Qualifications:
Other Skills/Competencies:
Organization, follow-through, effective communication, and computer literacy.
Attention to detail, organization, time management, and effective communication is needed for this position.
Action Oriented, Conflict Management, Customer Focus, Functional / Technical Skills, Presentation Skills, Priority Setting, Written Communication
Demand for labels and record retrieval creates interruptions.
A high degree of concentration is required to prevent mix-up and consequent labeling errors.
RELATIONSHIP WITH OTHERS/ SCOPE:
WORKING CONDITIONS:
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
Quality Analyst II
Requisition
JR000013799 Quality Analyst II (Open)
Location
Raleigh, NC (Pharma) - USA033
Additional Locations
Raleigh, NC
Job Description
SUMMARY OF POSITION:
The Quality Analyst II serves as the primary for batch record review. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts.
ESSENTIAL FUNCTIONS:
- Programs label changes and add new codes to the labeling computer.
- Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel.
- Issues final product labels and batch records to production.
- Complete proper archival of batch records to including but not limited to, batch record scanning, documentation error tracking and corrections, and label reconciliation.
ADDITIONAL FUNCTIONS:
- Function as a Primary back-up for the Raleigh site for customer inquiries and required documentation for GMP customer requests.
- Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both, QA, and QC as well as filing.
- Provide support to investigations, both exceptions and OOSs, to support product disposition.
- Provide support to intermediate labeling and tank inspections as needed.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
- Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
- Provide administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines.
MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent.
Associates or Technical degree or higher preferred.
Experience:
Competency in MS Word, Excel, and Adobe is required.
1-3 years pharmaceutical manufacturing experience preferred.
Preferred Skills/Qualifications:
Other Skills/Competencies:
Organization, follow-through, effective communication, and computer literacy.
Attention to detail, organization, time management, and effective communication is needed for this position.
Action Oriented, Conflict Management, Customer Focus, Functional / Technical Skills, Presentation Skills, Priority Setting, Written Communication
Demand for labels and record retrieval creates interruptions.
A high degree of concentration is required to prevent mix-up and consequent labeling errors.
RELATIONSHIP WITH OTHERS/ SCOPE:
- This position reports Quality Manager and indirectly to the Site Quality Director
- Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks.
- This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.
- No employees directly reporting to this position.
- This position requires self-motivation and daily execution of tasks with limited supervision interaction.
WORKING CONDITIONS:
- General normal office and meeting room conditions but must complete some routine assignments in plant and non-air-conditioned production environment.
- Ability to adjust schedule as needed to assure early week shipments.
- Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
